FDA
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
FEATURED STORIES
The Senate failed to pass a massive spending bill on Thursday—which includes the rare pediatric PRV program but also funding for the Immigration and Customs Enforcement’s large-scale crackdown in Minnesota and other states.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
Together with robust data-driven modeling, rethinking regulation and data use could push forward a notoriously challenging field.
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May is a busy month for the U.S. Food and Drug Administration (FDA)’s calendar for new drug reviews. Here’s a look.
A final analysis of AstraZeneca’s Phase III POSEIDON trial shows IMFINZI (durvalumab), offered improvements in overall survival (OS) when added to tremelimumab and chemotherapy versus chemotherapy alone in patients with Stage IV (metastatic) non-small cell lung cancer.
The FDA released a briefing document that expressed concerns over ChemoCentryx’s avacopan. Company shares plummeted 46.5% at the news.
Six months after receiving Emergency Use Authorization from the U.S. FDA for COVID-19 vaccines, Pfizer/BioNTech and Moderna are planning to seek full approval for the preventative medications.
Bluebird bio reported first-quarter earnings, the approval of Abecma, the first CAR-T therapy for relapsed or refractory multiple myeloma, and its spinout, 2seventy bio, and its leadership.
Less than two weeks after receiving the greenlight for Zynlonta under accelerated approval, ADC Therapeutics has launched its treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma.
With Biogen’s potential treatment for Alzheimer’s, aducanumab, coming in weeks before a U.S. FDA decision, ICER wrote a punishing report slamming the drug for insufficient efficacy and recommending a low price point if approved.
The U.S. FDA approved Keytruda combined with Genentech’s Herceptin (trastuzumab), fluoropyrimidine- and platinum-containing chemotherapy, for first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.
BioSpace takes a look at data released this week from some of the numerous ongoing clinical studies to advance potential therapies and treatment for disease. Here are some of them.
The U.S. FDA cites concerns regarding clinical data for ChemoCentryx’s investigational rare autoimmune disease therapy avacopan. Shares in the company plunged 46.5% lower following the release of the document.